Clinical Trial - NCT02636855

Screening Protocol for Tumor Antigen Expression Profiling and HLA Typing for Eligibility Determination

Recruiting

Sponsor: Adaptimmune

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02636855

Protocol Info

Short Description: Screening Protocol to Determine Tumor Antigen Expression and HLA Sub-Type
Long Description: A Screening Protocol to Determine Tumor Antigen Expression and HLA Sub-Type for Eligibility Determination for Clinical Trials Evaluating the Safety and Efficacy of Autologous T Cells Expressing Enhanced TCRs in Subjects with Non-Small Cell Lung Cancer (NSCLC)
MGH Status: Open
Sponsor: Adaptimmune
Disease Program: Cellular

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

This screening study is intended for men and women at least 18 years of age who have advanced solid or hematologic malignancy. The study will assess a subject's human leukocyte antigen (HLA) subtype and tumor antigen expression profile. Based on the results, it will be determined if a subject is eligible to be considered for Adaptimmune sponsored clinical trials testing the safety and efficacy of genetically changed T cells targeting specific tumor antigens. No treatment intervention will occur as part of this screening study. Upon enrollment, subjects will be required to provide a blood sample for HLA subtype analysis. If the results of the analysis match the HLA-A subtypes noted in the inclusion criteria and do not express the HLA subtypes that are exclusionary for the available interventional clinical trial(s), then the subject will be required to provide either an archival tumor specimen or fresh tumor tissue biopsy. The tumor specimen will be screened at a central laboratory for the expression (protein or gene) of multiple antigens which may include, but are not limited to NY-ESO-1 and/or LAGE-1a and MAGE A10. Based upon the results of these diagnostic analyses, if eligible, subjects will be referred to an appropriate available interventional clinical trial(s) at the discretion of the Investigator. Following screening, tumor samples will be retained by Adaptimmune for the purpose of developing and validating in vitro diagnostic (IVD) assay(s) for antigen expression profiling which is required for regulatory approval of a new therapeutic product indication.
Condition Title Intervention Phase
Solid and Hematological Malignancies
Study Type Observational
Official Title A Screening Protocol to Determine Tumor Antigen Expression and HLA Sub-Type for Eligibility Determination for Clinical Trials Evaluating the Safety and Efficacy of Autologous T Cells Expressing Enhanced TCRs in Subjects With Solid and Hematological Malignancies

Primary Outcome Measures

Frequency of subjects with the expression (gene or protein) of multiple antigens (including, but are not limited to NY-ESO-1 and/or LAGE-1a, MAGE A10, and others) [Time Frame: 10 years] [Designated as safety issue: ]


Secondary Outcome Measures

Retention of screening tumor tissue for the future development and validation of single and/or multi-plex companion diagnostic platforms for the detection of tumor antigen expression. [Time Frame: 10 years] [Designated as safety issue: ]

Estimated Enrollment: 300
Study Start Date: December 2015
Estimated Study Completion Date: November 2025
Estimated Primary Completion Date: November 2025

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

Inclusion Criteria

1. Signed written informed consent;

2. Histologically or cytologically confirmed diagnosis of advanced solid or hematologic malignancy or recurrent disease, as described in the respective Adaptimmune clinical treatment protocol (including, but not limited to myeloma, melanoma, NSCLC, head and neck, gastric and bladder cancer);

3. Male or female = 18 years of age;

4. Life expectancy > 3 months;

5. Ability to provide a blood sample;

6. Ability to provide one of the following tumor tissue samples:

i. formalin-fixed, paraffin-embedded (FFPE) tumor block or tissue sections from a current lesion/the most current setting, or a fresh biopsy is feasible, OR;

ii. a FFPE archival primary tumor block or tissue sections

Exclusion Criteria:

1. Any bleeding diathesis or coagulopathy, which at the discretion of the Investigator may put the subject at risk.

2. Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the screening study procedures.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02636855

Locations

  • United States, California
    • City of Hope Duarte, California, United States, 91101
    • Stanford Cancer Institute (Stanford University) Stanford, California, United States, 94305
  • United States, Florida
    • Boca Raton Regional Hospital, Lynn Cancer Institute, 701 NW 13th Street Boca Raton, Florida, United States, 33486
    • University of Miami, Sylvester Comprehensive Cancer Center Miami, Florida, United States, 33136
    • H. Lee Moffitt Cancer Center Tampa, Florida, United States, 33612
  • United States, Georgia
    • Winship Cancer Institute - Emory University Atlanta, Georgia, United States, 30322
  • United States, Indiana
    • Indiana University Simon Cancer Center Indianapolis, Indiana, United States, 46033
  • United States, Maryland
    • University of Maryland, Greenebaum Cancer Center Baltimore, Maryland, United States, 21157
    • Upper Chesapeake Medical Center, Patricia D. and M. Scot Kaufman Cancer Center Bel Air, Maryland, United States, 21014
    • UM St. Joseph Medical Center Towson, Maryland, United States, 21204
  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
  • United States, Missouri
    • Washington University School of Medicine Saint Louis, Missouri, United States, 63110
  • United States, New York
    • Roswell Park Cancer Institute Buffalo, New York, United States, 14040
  • United States, North Carolina
    • Duke University Medical Center, Duke Cancer Institute Durham, North Carolina, United States, 27710
  • United States, Ohio
    • Ohio State University Wexner Medical Center Columbus, Ohio, United States, 43210
  • United States, Oklahoma
    • University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma, United States, 73104
  • United States, Pennsylvania
    • Thomas Jefferson University Hospital Philadelphia, Pennsylvania, United States, 19107
    • Fox Chase Cancer Center Philadelphia, Pennsylvania, United States, 19111
  • United States, Tennessee
    • Tennessee Oncology- Sarah Cannon Research Institute Nashville, Tennessee, United States, 37203
  • United States, Texas
    • The University of Texas MD Anderson Cancer Center Houston, Texas, United States, 77030
  • United States, Wisconsin
    • Medical College of Wisconsin Milwaukee, Wisconsin, United States, 53226
  • Canada, Ontario
    • Princess Margaret Cancer Centre Toronto, Ontario, Canada, M5G 2M9
  • Spain,
    • Hospital Universitario Fundación Jiménez Díaz Madrid, , Spain, 28040
    • Hospital Universitario 12 Octubre Avda. de Córdoba s/n Madrid, , Spain, 28041
  • United Kingdom,
    • University College Hospital Macmillan Cancer Centre London, , United Kingdom, WC1E 6AG
    • The Christie NHS Foundation Trust Manchester, , United Kingdom, M20 4BX

Sponsors and Collaborators

Adaptimmune

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02636855
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Adaptimmune:

Solid and Hematological Malignancies

Screening

Metastatic

Previously Treated

NY-ESO-1

MAGE A10

MAGE-A4

Additional relevant MeSH terms:

Neoplasms

Hematologic Neoplasms

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on November 12, 2020